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OpenTrials
Completed

NCT Number: NCT01965769

Effects Of Not Measuring Gastric Residual Content On Feeding Tolerance In Premature Infants iNFANTS

Omitting evaluation of gastric residual contents prior to feeding very premature infants will increase the feeding intake at 2 weeks, and total caloric intake and growth by 3 weeks, as well as decrease the time required for parenteral nutrition.

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Key information

Conditions

Premature Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF & Shands Hospital

Gainesville, Florida, 32611, United States

About this study

Infants were randomized into 2 groups. Group 1 had no gastric residuals evaluated prior to feeding. Group 2 had gastric residuals evaluated prior to feeding. Nutritional outcomes were compared between groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age less than 32 weeks,
  • Birth weight less than or equal to 1250 grams,
  • Initial feeding tolerated within 48 hours of life

Exclusion criteria

  • Congenital or chromosomal disorders,
  • Severe complications leading to death in the first week of life

Treatment and study plan

No gastric residual evaluation

Other

Infants will not receive routine gastric residual evaluation prior to feeding.

Primary outcomes

  1. Amount of feeding intake at 2 weeks

    Time frame: Baseline to 2 weeks

Secondary outcomes

  1. Days to 120 mL/kg/d of enteral feedings

    Time frame: Baseline to approximately 21 days

  2. Days of parenteral nutrition

    Time frame: Baseline to approximately 21 days

  3. Incidence of late onset sepsis

    Time frame: Baseline to approximately 90 days

  4. Weekly or biweekly liver function tests

    Time frame: Baseline to 42 days

    Direct bilirubin

  5. Growth indices

    Time frame: Baseline to approximately 90 days

    Weight, length and head circumference

  6. Length of hospital stay

    Time frame: Baseline to approximately 90 days

  7. Incidence of necrotizing enterocolitis

    Time frame: Baseline to approximately 90 days

  8. Days requiring a central venous line

    Time frame: Baseline to approximately 21 days

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • The Gerber Foundation

Registry information

Official study title

Effects Of Not Measuring Gastric Residuals Prior To Enteral Bolus Feeding On Gastrointestinal Function And Feeding Tolerance In Very Low Birth Weight Infants

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 18, 2013
Registry last updated
Oct 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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